Have You or a Loved One Received a Health Insurance Denial for Entyvio? We Can Help.
Approved by The Food and Drug Administration (FDA) in May 2014, Entyvio® treats ulcerative colitis and Crohn’s disease. Takeda Pharmaceuticals’ Entyvio (vedolizumab) is a biologic medication that targets inflammation in the gastrointestinal tract. It is in a class called, “integrin receptor antagonists.” It works by binding to α4β7 integrin, a mediator of GI inflammation. In clinical trials, Entyvio showed a response at week 6 of treatment and long-term remission in some patients at week 52. This article reviews Entyvio health insurance coverage claims and how health insurance companies determine medical necessity. Medical necessity typically is required from UnitedHealthcare, Kaiser Permanente, Blue Shield, Anthem Blue Cross, and other health insurers. The article also covers what you can do if you receive an Entyvio health insurance denial. If you receive an Entyvio health insurance denial, contact the Law Offices of Scott Glovsky.
What is Entyvio?
Entyvio is a prescription medication for adults with moderate to severe Crohn’s disease or ulcerative colitis. It is a monoclonal antibody biologic medication that binds to integrin α₄β₇. This binding helps reduce inflammation in the gut by helping stop too many white blood cells from entering the GI tract. Entyvio helps with both long-term symptom relief and remission.
What Illnesses does Entyvio Treat?
Physicians prescribe Entyvio for moderate to severe ulcerative colitis and Crohn’s disease. Entyvio is typically prescribed for patients who have not responded well to or who cannot tolerate other medicines. It is also for people currently using steroids to treat their flare-ups.
How is Entyvio Administered?
Entyvio is administered intravenously into a vein in the arm. Patients receive infusions in healthcare settings like a doctor’s office, infusion center, or hospital. Sometimes a medical practitioner administers Entyvio in a patient’s home. Each infusion lasts about 30 minutes.
How Often Do You Need to Take Entyvio?
There are 3 initial doses of 300 mg at weeks 0, 2, and 6. Follow-up doses are every 8 weeks starting at week 14. So there are 8 doses in the first year and 6 doses in future years.
Are There Risks With Entyvio?
While on Entyvio, patients have a higher risk of getting an infection. Other risks include allergic reactions, liver issues, and PML. See the medication guide for Entyvio here.
How Much Does Entyvio Cost?
The suggested retail price for a 30-day supply of Entyvio is $3,898.19. This is quite expensive, and most people rely on their health insurance coverage to get this treatment.
Are There Alternative Drugs to Entyvio?
Doctors often start patients on treatments or alternate drugs that are less expensive. The alternative selected depends on the specific health condition treated. Below is a list of some alternatives:
Crohn’s Disease:
Biologics are expensive. So sometimes doctors start with anti-inflammatory medications such as corticosteroids or oral 5-aminosalicylates. Physicians may also prescribe immune system suppressors like mercaptopurine and azathioprine as well as methotrexate. Some others include anti-diarrheals, antibiotics, pain relievers and more. Biologics approved by the FDA include Stelara (ustekinumab), Humira (adalimumab) and Remicade (Infliximab).
Ulcerative Colitis:
Like with Crohn’s disease, physicians often begin with anti-inflammatory medications and immune system suppressors. Biologics recommended may include Entyvio, Humira, Simponi, Entyvio, and Stelara.
Will I Receive Health Insurance Denial for Entyvio?
Government health insurers like Medicare, aka Medi-Cal in CA, and Medicaid are likely to cover Entyvio because these medications are approved by the FDA. These insurers often cover FDA approved medications. Even so, coverage varies by state. Note that Medicare Part D generally does not cover Entyvio. But Medicare Part B may cover this medication. Medicare and Medicaid may rely on national guidelines from independent organizations like the National Comprehensive Cancer Network for cancer medications and treatments.
It is important to keep in mind that all insurance companies are different. UnitedHealthcare, Anthem Blue Cross, Blue Shield of California, Cigna, Kaiser and others have different internal policies. While this is covered later in the article, insurer policies depend on how each one evaluates new drugs and a potential Entyvio health insurance denial.
Is Entyvio Medically Necessary or Medically Beneficial?
When insurers cover Entyvio, they consider it “medically necessary.” They also will likely require a prior authorization. Medical necessity means that the insurance company accepts that Entyvio is necessary to treat your condition. Unfortunately, sometimes prior authorization is not easy to attain from the insurance company.
Medically beneficial means that the drug is beneficial but not necessary for a condition. The insurer might have policies stating there are other treatments or medications for your specific health disorder. And perhaps the insurer wants you to try less expensive medications first. We know that Entyvio is an expensive biologic medication.
When your insurance company wants you to try a different medication or treatment first, it is known as “Step Therapy.” In the state of California, most insurance companies require you to try the alternative for at least 60 days. Unfortunately, if the alternative doesn’t work, you will likely suffer the same symptoms during this period. So testing alternatives may just prolong your symptoms. We get calls from frustrated patients saying health insurance companies are playing doctor instead of listening to their physicians.
How Do Different Health Insurance Companies Evaluate Entyvio Claim Requests?
Each company creates its own medical and/or pharmacy policies. The policies include internal clinical standards on the circumstances and situations in which medications and treatments are “medically necessary.” (And approved drugs are included in their “formularies.”) Health insurance companies track new pharmaceuticals approved by the FDA. And their internal pharmacists research medical literature about the medications. Then, they give a recommendation on whether pharmaceuticals like Entyvio are medically necessary or experimental / investigational.
Health insurance companies likely take internal recommended policies to a team of external doctors who influence whether the policies are correct. But there may be other motivations weighing on external physician decisions. For example, this team is likely paid by the insurance companies. Because of this, there might be an enticement to affirm an overly limited policy. If the external doctors want to work for the insurer, they may want to agree with proposed policies. And we cannot forget that expensive medications impact the insurer’s profits which is another incentive for a restrictive policy.
Restrictive policies may not include what 3rd party specialist organizations determine is safe and effective for treating medical conditions. In fact, “generally accepted standards of medical practice” refers to standards based on credible scientific evidence that is published in peer-reviewed medical literature. They are generally recognized by the related medical community and are accepted by other healthcare practitioners in the community. Still, unfortunately an insurer’s policy may differ from what a patient’s doctor considers is medically necessary.
When is Entyvio Medically Necessary and when is it Deemed to be Experimental / Investigational?
“Experimental or investigational” is the term insurance companies use for medications or treatments they don’t think are “medically necessary.” At times, drugs approved by the FDA are considered experimental or investigational by the insurer. Why? Because of how insurers define experimental. For example, they may consider a drug that helps some but not all individuals as experimental. And this is the case for just about every medication on the market. So by this measure, just about any drug or treatment can be considered experimental or investigational. Even aspirin can be considered experimental.
Do Insurance Companies Have Obligations When Members Submit Claims?
Fortunately insurers have duties when their members submit claims. They must thoroughly investigate each claim or request for care. They need to search for all possible bases that may support the request for care. Insurance companies must respond quickly to a request for care. This is often 30 days in California. And finally, they cannot just have anyone reviewing claims. Insurance companies must have qualified health practitioners making utilization review decisions.
What Can You Do if You Receive a Health Insurance Denial for Entyvio?
The first thing to think about is an appeal for the Entyvio health insurance denial. But before doing so, you should consider if you have an ERISA or non-ERISA plan. You may not know which plan you have. If so, you might want to ask your internal HR representative or a plan administrator.
An ERISA plan is usually a plan provided by an employer. But not always. Here are examples of non-ERISA plans:
- plans for government or public employees
- those for religious organizations like churches and temples
- plans bought from Covered California that are individual and family plans
- those for small businesses that only cover the owners
- and most plans bought from private insurance companies. These insurers include UnitedHealthcare, Blue Shield of California, Healthnet, Kaiser, Anthem Blue Cross, Aetna, and others.
People with ERISA plans should speak with an ERISA attorney first and then file an appeal. You can learn more about ERISA plans and what to do here. But individuals with non-ERISA plans have many options. You should know the reason for the denial. Learn more about non-ERISA plans and what you can do here.
Contact Law Offices of Scott Glovsky if You Receive a Health Insurance Denial for Entyvio
The Law Offices of Scott Glovsky has been representing injured consumers and victims of wrongful business practices since 1999. We focus on health insurance bad faith, catastrophic personal injury, sexual abuse and consumer-related litigation. We get justice for our clients and hold the wrongdoers accountable.